Job Description

• Support the end-to-end clinical data management process for assigned studies, from protocol review to database lock.
• Collaborate with cross-functional teams, including clinical operations, biostatistics, and medical writing, to define data collection and reporting needs.
• Review and finalize clinical data management documentation, such as Data Management Plans (DMP), Case Report Forms (CRFs), and data validation specifications.
• Ensure adherence to applicable regulatory guidelines (e.g., FDA, ICH, GCP) and company standards for data management.
• Perform data cleaning, query resolution, and reconciliation of external data sources (e.g., lab data, ePRO).
• Support database setup, testing, and maintenance in partnership with external vendors or internal teams.
• Perform quality control and audit activities to ensure data accuracy and compliance.
• Support data reviews and provide metrics and status updates to project teams and leadership.

Requirements:

• Bachelor's degree in Life Sciences, Computer Science, or a related field.
• Minimum of 3 years of clinical data management experience in the pharmaceutical, biotech, or CRO industry.
• Proficiency in electronic data capture (EDC) systems, such as Medidata Rave, Oracle Clinical, or similar platforms.
• Strong knowledge of CDISC standards, including SDTM and ADaM.
• Excellent understanding of clinical trial processes and regulatory requirements (e.g., FDA, EMA).
• Exceptional attention to detail and problem-solving skills.
• Ability to work independently and communicate effectively with diverse stakeholders.

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